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InvivoLight 6.0

by Anatomage, Inc.

InvivoLight 6.0 is a Class II device made by Anatomage, Inc., cleared under FDA 510(k) K123519 on 1 Feb 2013 and listed in FDA GUDID since 12 Jan 2018 (UDI-DI 00852060007068), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K123519

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00852060007068 UDI-DI Date12 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK123519 Date1 Feb 2013IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123519 decided 1 Feb 2013 Active
  • FDA GUDID UDI-DI 00852060007068 listed 12 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123519
  2. Listed FDA GUDID 00852060007068

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
InvivoLight
Generic name
Radiology information system application software
Model / reference
6.0
Primary DI / UDI-DI
00852060007068
510(k) Number
FDA product code
LLZ
GMDN term
Radiology information system application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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See all devices from Anatomage, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)